• Title/Summary/Keyword: Clinical Trials

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Is aggressive intravenous fluid prescription the answer to reduce mortality in severe pancreatitis? The FLIP study: Fluid resuscitation in pancreatitis

  • Julia McGovern;Samuel J Tingle;Northern Surgical Trainees Research Association (NOSTRA);Stuart Robinson;John Moir
    • Annals of Hepato-Biliary-Pancreatic Surgery
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    • v.27 no.4
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    • pp.394-402
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    • 2023
  • Backgrounds/Aims: Acute pancreatitis is an emergency presentation, which can range from mild to life threatening. Intravenous fluids are the cornerstone of management. Although the WATERFALL trial described the optimal fluid rate in mild/moderate pancreatitis, this trial excluded patients with moderate-severe/severe pancreatitis. The aim of this study was to establish clinical practice regarding intravenous fluid administration in acute pancreatitis and assess its effect on mortality. Methods: Prospective multi-centre audit of patients with acute pancreatitis was conducted. Data were collected regarding intravenous fluid administration within 72 hours of admission. The primary outcome was 30-day mortality. Multivariable logistic regression was used to identify predictors of 30-day mortality. Results: Those with severe pancreatitis received more fluid; median 5.7 L versus 4 L in 72 hours (p = 0.003). Participants with severe pancreatitis who died within 30 days received a median of 2,750 mL in the first 24 hours, compared to 4,000 mL in those who survived. The following factors were significant predictors of 30-day mortality: age, Glasgow score, C-reactive protein, ischaemic heart disease, and pancreatitis aetiology. Overall, volume of intravenous fluid was not associated with mortality. However, the effect of intravenous fluid volume on mortality differed significantly depending on pancreatitis severity. In severe pancreatitis, increased volume of intravenous fluid was associated with significant reductions in mortality (odds ratio = 0.655; 0.459-0.936; p = 0.020). Conclusions: In severe pancreatitis, more aggressive fluid prescription was associated with decreased mortality; however, this was not the case in milder disease. Further prospective trials guiding fluid resuscitation in severe pancreatitis are needed, as the impact of fluid on this population appears to differ from that in those with milder disease.

Hybrid argon plasma coagulation in Barrett's esophagus: a systematic review and meta-analysis

  • Sagar N. Shah;Nabil El Hage Chehade;Amirali Tavangar;Alyssa Choi;Marc Monachese;Kenneth J. Chang;Jason B. Samarasena
    • Clinical Endoscopy
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    • v.56 no.1
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    • pp.38-49
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    • 2023
  • Background/Aims: Patients with Barrett's esophagus are at increased risk of developing esophageal adenocarcinoma. Endoscopic therapies aim to eradicate dysplastic and metaplastic tissues. Hybrid argon plasma coagulation (hybrid-APC) utilizes submucosal fluid injection to create a protective cushion prior to ablation that shields the submucosa from injury. We performed a pooled meta-analysis to evaluate the safety and efficacy of hybrid-APC. Methods: We conducted a systematic search of major electronic databases in April 2022. Studies that included patients with dysplastic and non-dysplastic Barrett's esophagus undergoing treatment with hybrid-APC were eligible for inclusion. Outcome measures included complete remission of intestinal metaplasia (CR-IM), stricture formation, serious adverse events, and number of sessions necessary to achieve CR-IM. Results: Overall pooled CR-IM rate for patients undergoing hybrid-APC was 90.8% (95% confidence interval [CI], 0.872-0.939; I2=0%). Pooled stricture rate was 2.0% (95% CI, 0.005-0.042; I2=0%). Overall serious adverse event rate was 2.7% (95% CI, 0.007-0.055; I2=0%). Conclusions: Results of the current meta-analysis suggest that hybrid-APC is associated with high rates of CR-IM and a favorable safety profile. Interpretation of these results is limited by the inclusion of retrospective cohort and case series data. Randomized controlled trials that standardize treatment and outcome evaluation protocols are necessary to understand how this treatment option is comparable to the current standards of care.

A Systematic Review of Traditional Herbal Medicine Treatments for Metabolic Syndrome in Patients Receiving Antipsychotic Drugs (항정신병약물 복용 환자의 대사증후군에 대한 한약치료의 체계적 문헌고찰)

  • Sun-Woo Lim;O-Reun Park;So-Hyeon Park;Sung-Youl Choi;Bo-Kyung Kim;Jung-Hwa Lim
    • Journal of Oriental Neuropsychiatry
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    • v.35 no.1
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    • pp.69-99
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    • 2024
  • Objectives: This study aimed to systematically review the effectiveness and safety of traditional herbal medicine treatments for metabolic syndrome (MS) in patients receiving antipsychotic drugs (APs). Methods: We searched 11 domestic and foreign databases for randomized controlled trials (RCTs) using traditional herbal medicines for MS in patients receiving APs. Results: Twenty RCTs conducted in China were included in the analysis. The most common disease among the participants was schizophrenia. Most studies used the 2004 Chinese Diabetes Society (CDS) standards as the diagnostic criteria for MS. The most used prescription was Yukultang (Liuyu-tang). The most used herbal material was Pinelliae Rhizoma, followed by Poria, Citri Reticulatae Pericarpium, and Glycyrrhizae Radix et Rhizoma. Traditional herbal medicines were mostly reported to improve the symptoms of MS. Conclusions: Traditional herbal medicines may be effective in improving the symptoms of MS in patients receiving APs. However, the quality of the included studies was low, and the studies were heterogeneous. Methodologically rigorous clinical studies on traditional herbal medicine treatments for MS in patients receiving APs are needed.

Radiological Recurrence Patterns after Bevacizumab Treatment of Recurrent High-Grade Glioma: A Systematic Review and Meta-Analysis

  • Se Jin Cho;Ho Sung Kim;Chong Hyun Suh;Ji Eun Park
    • Korean Journal of Radiology
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    • v.21 no.7
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    • pp.908-918
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    • 2020
  • Objective: To categorize the radiological patterns of recurrence after bevacizumab treatment and to derive the pooled proportions of patients with recurrent malignant glioma showing the different radiological patterns. Materials and Methods: A systematic literature search in the Ovid-MEDLINE and EMBASE databases was performed to identify studies reporting radiological recurrence patterns in patients with recurrent malignant glioma after bevacizumab treatment failure until April 10, 2019. The pooled proportions according to radiological recurrence patterns (geographically local versus non-local recurrence) and predominant tumor portions (enhancing tumor versus non-enhancing tumor) after bevacizumab treatment were calculated. Subgroup and meta-regression analyses were also performed. Results: The systematic review and meta-analysis included 17 articles. The pooled proportions were 38.3% (95% confidence interval [CI], 30.6-46.1%) for a geographical radiologic pattern of non-local recurrence and 34.2% (95% CI, 27.3-41.5%) for a non-enhancing tumor-predominant recurrence pattern. In the subgroup analysis, the pooled proportion of non-local recurrence in the patients treated with bevacizumab only was slightly higher than that in patients treated with the combination with cytotoxic chemotherapy (34.9% [95% CI, 22.8-49.4%] versus 22.5% [95% CI, 9.5-44.6%]). Conclusion: A substantial proportion of high-grade glioma patients show non-local or non-enhancing radiologic patterns of recurrence after bevacizumab treatment, which may provide insight into surrogate endpoints for treatment failure in clinical trials of recurrent high-grade glioma.

Therapeutic Effect of Crocin in Inflammatory Diseases (염증성 질환에 대한 Crocin의 치료 효과)

  • YoungHee Kim
    • Journal of Life Science
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    • v.34 no.2
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    • pp.138-144
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    • 2024
  • Crocin is a major carotenoid of the Gardenia jasminoides fruit and Crocus sativus stigma (saffron), which are used in various cuisines as flavoring and coloring agents, as well as in phytomedicine for the treatment of several disorders, including headache, fever, edema, fatty liver, viral hepatitis, respiratory disease, menstruation disorders, insomnia, and hypertension. Crocin (C44H64O24) is a chemical diester composed of the dicarboxylic acid crocetin and disaccharide gentiobiose. Many in vitro and in vivo studies have been conducted about the biological and pharmacological function and toxicity of crocin. Crocin has been revealed to have no genotoxicity and pathological manifestation. Crocin acts as an antioxidant, anti-cancer, memory enhancer, anxiolytic, antidepressant, aphrodisiac, anti-atherosclerotic, cardioprotector, and hepatoprotector. Here, an inclusive review of crocin is introduced based on previously explored studies referred to in the literature. Different studies have confirmed the protective role of crocin in the pathogenesis of inflammatory diseases, including inflammatory bowel diseases, gastritis, asthma, atherosclerosis, rheumatoid arthritis, multiple sclerosis, type 1 diabetes, Alzheimer's disease, Parkinson's disease, and depression. It is surmised that crocin suppresses inflammatory, antioxidant, and apoptotic processes through multiple mechanisms. Crocin is considered a safe and effective therapeutic choice for patients with inflammatory conditions, although more research investigating its mechanisms and results acquired in clinical trials are needed.

Harnessing the Power of Voice: A Deep Neural Network Model for Alzheimer's Disease Detection

  • Chan-Young Park;Minsoo Kim;YongSoo Shim;Nayoung Ryoo;Hyunjoo Choi;Ho Tae Jeong;Gihyun Yun;Hunboc Lee;Hyungryul Kim;SangYun Kim;Young Chul Youn
    • Dementia and Neurocognitive Disorders
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    • v.23 no.1
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    • pp.1-10
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    • 2024
  • Background and Purpose: Voice, reflecting cerebral functions, holds potential for analyzing and understanding brain function, especially in the context of cognitive impairment (CI) and Alzheimer's disease (AD). This study used voice data to distinguish between normal cognition and CI or Alzheimer's disease dementia (ADD). Methods: This study enrolled 3 groups of subjects: 1) 52 subjects with subjective cognitive decline; 2) 110 subjects with mild CI; and 3) 59 subjects with ADD. Voice features were extracted using Mel-frequency cepstral coefficients and Chroma. Results: A deep neural network (DNN) model showed promising performance, with an accuracy of roughly 81% in 10 trials in predicting ADD, which increased to an average value of about 82.0%±1.6% when evaluated against unseen test dataset. Conclusions: Although results did not demonstrate the level of accuracy necessary for a definitive clinical tool, they provided a compelling proof-of-concept for the potential use of voice data in cognitive status assessment. DNN algorithms using voice offer a promising approach to early detection of AD. They could improve the accuracy and accessibility of diagnosis, ultimately leading to better outcomes for patients.

Does computer-aided diagnostic endoscopy improve the detection of commonly missed polyps? A meta-analysis

  • Arun Sivananthan;Scarlet Nazarian;Lakshmana Ayaru;Kinesh Patel;Hutan Ashrafian;Ara Darzi;Nisha Patel
    • Clinical Endoscopy
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    • v.55 no.3
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    • pp.355-364
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    • 2022
  • Background/Aims: Colonoscopy is the gold standard diagnostic method for colorectal neoplasia, allowing detection and resection of adenomatous polyps; however, significant proportions of adenomas are missed. Computer-aided detection (CADe) systems in endoscopy are currently available to help identify lesions. Diminutive (≤5 mm) and nonpedunculated polyps are most commonly missed. This meta-analysis aimed to assess whether CADe systems can improve the real-time detection of these commonly missed lesions. Methods: A comprehensive literature search was performed. Randomized controlled trials evaluating CADe systems categorized by morphology and lesion size were included. The mean number of polyps and adenomas per patient was derived. Independent proportions and their differences were calculated using DerSimonian and Laird random-effects modeling. Results: Seven studies, including 2,595 CADe-assisted colonoscopies and 2,622 conventional colonoscopies, were analyzed. CADe-assisted colonoscopy demonstrated an 80% increase in the mean number of diminutive adenomas detected per patient compared with conventional colonoscopy (0.31 vs. 0.17; effect size, 0.13; 95% confidence interval [CI], 0.09-0.18); it also demonstrated a 91.7% increase in the mean number of nonpedunculated adenomas detected per patient (0.32 vs. 0.19; effect size, 0.05; 95% CI, 0.02-0.07). Conclusions: CADe-assisted endoscopy significantly improved the detection of most commonly missed adenomas. Although this method is a potentially exciting technology, limitations still apply to current data, prompting the need for further real-time studies.

Middle meningeal artery embolization for chronic subdural hematoma in elderly patients at high risk of surgical treatment

  • Jin Hoo Seok;Jong Hyun Kim;Taek Hyun Kwon;Joonho Byun;Won Ki Yoon
    • Journal of Cerebrovascular and Endovascular Neurosurgery
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    • v.25 no.1
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    • pp.28-35
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    • 2023
  • Objective: The purpose of this study was to evaluate the effectiveness of middle meningeal artery embolization (MMAE) in elderly high-risk patients with symptomatic chronic subdural hematoma (CSDH) in terms of reduction in hematoma volume and recurrence rate. Methods: We retrospectively reviewed data prospectively collected from nine patients who underwent 13 MMAE for CSDH between June 2017 and May 2022. The volume of the subdural hematoma was measured using a computer-aided volumetric analysis program. Hematoma volume changes during the follow-up period were analyzed and clinical outcomes were evaluated. Results: The mean follow-up period was 160 days (range, 46-311 days). All procedures were technically successful and there were no procedure-related complications. Of the 13 MMAE, 84% (11 out of 13 hemispheres) showed mean 88% of reduction on follow-up volumetric study with eight cases of complete resolution. There was one refractory case with MMAE which had been performed multiple burr-hole trephinations, for which treatment was completed by craniotomy and meticulous resection of multiple pseudomembranes. There was no recurrent case during the follow-up period, except for refractory case. Conclusions: MMAE for CSDH in selected high-risk elderly patients and relapsed patients might be effective. Despite the small cohort, our findings showed a high rate of complete resolution with no complications. Further prospective randomized trials are warranted to evaluate its usefulness as a primary treatment option for CSDH.

Effect of belimumab in patients with systemic lupus erythematosus treated with low dose or no corticosteroids

  • Yeo-Jin Lee;Soo Min Ahn;Seokchan Hong;Ji-Seon Oh;Chang-Keun Lee;Bin Yoo;Yong-Gil Kim
    • The Korean journal of internal medicine
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    • v.39 no.2
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    • pp.338-346
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    • 2024
  • Background/Aims: Systemic lupus erythematosus (SLE) responder index (SRI)-4 response has been achieved with belimumab treatment in patients with moderate disease activity in cornerstone clinical trials and following studies. However, most studies involved patients treated with a mean prednisolone-equivalent dose of approximately 10 mg/d and focused on the steroid-sparing effect of belimumab. We aimed to identify the effect of belimumab in patients with mild-to-moderate SLE who were treated with low-dose or no corticosteroids. Methods: We retrospectively reviewed the electronic medical records of patients treated with belimumab for at least 6 months between May 2021 and June 2022. The primary endpoint was SRI-4 response at 6 months. Results: Thirty-one patients were included (13 low dose- and 18 steroid non-users). The mean age was 39.2 ± 11.4 years, and 90.3% of patients were female. The baseline Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score was 6.0 (4.0-9.0). The primary endpoint was achieved in 32.3% (10/31) of patients. Significant improvements in anemia, C4 levels, and SELENA-SLEDAI score were observed during treatment. Univariate analysis showed that the baseline SELENA-SLEDAI and arthritis were significantly associated with SRI-4 response at 6 months, and only the SELENA-SLEDAI remained significant (p = 0.014) in multivariate analysis. Conclusions: This cohort study is the first to report the efficacy of belimumab after minimizing the effect of corticosteroids. Belimumab showed efficacy in improving the SELENA-SLEDAI score, anemia, and low C4 in patients who did not receive corticosteroids or received only low doses.

A Randomized trial to investigate the effect of Asparagus racemosus root tablet in Relieving Postmenopausal Hot Flashes

  • K.M. Hina Fatima;Mariyam Roqaiya;Nawazisha
    • CELLMED
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    • v.14 no.10
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    • pp.10.1-10.6
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    • 2024
  • Background and Objectives: As per the available data, 75% peri and postmenopausal women experience hot flashes having negative effect on their quality of life. Using herbal medicines are stepping forward to alleviate hot flashes as the available hormonal medications have been reported the presence of side effects. This study was planned with the intention to investigate the effect of Asparagus racemosus root in the treatment of postmenopausal hot flashes in comparison to the placebo. Methods: This prospective patient blinded clinical trial randomly assigned 40 postmenopausal women with symptoms of hot flashes to receive either test drug (n=20) comprising Asparagus racemosus tablet of 1g in the dosage of 2 tablet thrice in a day for the duration of 60 days continuously or to receive placebo tablet prepared from roasted wheat flour in the same dosage and duration as test drug. The efficacy was determined by reduction in the frequency and intensity of hot flashes assessed by daily diary along with the improvement in quality of life assessed through Hot Flash-Related Daily Interference Scale. Statistical analysis was accomplished by student t test and Chi-square/Fisher Exact test. Results: Test drug significantly (p <0.001) reduced the intensity and frequency of hot flashes as well as improved the quality of life without showing any side effect. Discussion & Conclusion: According to Unani scriptures, the treatment is to treat the underlying cause, such as aberrant temperament and psychological and environmental issues. Unani drugs have emmenagogue, anti-inflammatory, analgesic, and neuroprotective qualities that can help alleviate premenstrual symptoms. Unani herbs such as C. sativus, Vitex, agnus castus, P. vulgare, N. Jatamansi, M. officinalis, and Z. officinalis have been clinically demonstrated to be effective in PMS. Thus, traditional knowledge authentication and conservation are vital for future research and appreciated for application in the modern day. Furthermore, randomised controlled trials, comprehensive reviews, and meta-analyses are suggested.